2023-02106: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for orally administered immediate- release solid oral dosage forms, such as tablets, capsules, and granules/powders for oral suspension. The draft guidance is intended to provide globally harmonized scientific recommendations for conducting BE studies during both development and postapproval phases for these products.
The agency’s own summary, as published.
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